Beta-cryptoxanthin (BCX) is a naturally occurring member of the carotenoid family, found in a wide range of fruits and vegetables. The unique biological functions of BCX have not been well-established, although BCX, like other members of the carotenoids have antioxidant functions. BCX, may also serve as a precursor of Vitamin A. Vitamin A has a wide range of functions including maintain immunity, vision, growth and development. Whilst not specific for BCX, epidemiological studies indicate that dietary intake of carotenoids may be of benefit in maintaining cognitive health and reducing stress via its antioxidant, anti-inflammatory and immunomodulatory properties. This pilot study aims to establish the relationship between supplemental dose and circulating concentrations of BCX and related carotenoids in circulation. Results obtained from this study will provide greater insight of bioavailability and carotenoid metabolism, necessary for larger supplementation in selected target populations.
In previous Singapore maternal and child health cohort study, Growing up towards healthy outcomes (GUSTO), it established potentially significant health function to be significantly correlated with BCX. At childbirth, mothers' blood concentrations of carotenoids, including α-, β-carotene and BCX were simultaneously measured by ultra-performance liquid chromatography. Unique to the carotenoids, there was a correlation between higher maternal plasma concentrations of BCX with lower rates of depression and reduced anxiety scores during pregnancy for the mother. Furthermore, the concentrations of BCX were uniquely correlated with child neurocognitive function by age 2 years. Current studies have only been food-based efficacy trials with an increase of dietary BCX intake through BCX-rich foods in humans. There have been no direct assessments of risk associated with BCX exposure, and current evidence in the literature does not identify any consistent, substantial risks for any level of BCX supplementation. Overall, the utility of BCX as a pro-vitamin A is clear, but evidence towards benefits beyond this role is inconsistent. Hence, this is a pilot study that will aim to examine bioavailability of a novel BCX preparation supplemented at 2 doses (3mg and 6mg daily) versus placebo, consumed once daily in a randomised, doubled-blinded parallel trial, in healthy female subjects of reproductive age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
90
Subjects will be randomised into one of the three study treatment arms.
Singapore Institute for Clinical Sciences
Singapore, Singapore
Change in plasma concentration of BCX over 8 weeks
Fasting plasma carotenoids concentrations
Time frame: Baseline, Week 2, Week 4, Week 8
Height measurement
Height in centimeters (cm)
Time frame: Baseline
Change in weight
Weight in kilograms (kg)
Time frame: Baseline, Week 8
Change in Body Mass Index (BMI)
BMI in kg/m\^2 (from converted height in centimeters to meters)
Time frame: Baseline, Week 8
Change in waist circumference
Waist circumference in centimeters (cm)
Time frame: Baseline, Week 8
Change in body composition - Total body fat
Body fat analysis in percentage (%)
Time frame: Baseline, Week 8
Changes in General Health Questionnaire (GHQ-12) scores
\- GHQ-12 scores for measure of physiological distress
Time frame: Baseline, Week 8
Change in Pittsburgh Sleep Quality Index (PSQI) scores
\- PSQI scores for measures of sleep quality and patterns
Time frame: Baseline, Week 8
Change in State-Trait Anxiety Inventory (STAI) scores
\- STAI scores for measures of anxiety
Time frame: Baseline, Week 8
Change in Perceived Stress Scale (PSS) scores
\- PSS scores for measures of stress perceptions
Time frame: Baseline, Week 8
Change in Quality of Life Enjoyment and Satisfaction Questionnaire (QLES) scores
\- QLES scores for measures of the degree of life satisfaction
Time frame: Baseline, Week 8
Change in Satisfaction with Life Scale (SLS) scores
\- SLS scores for measures of subjective well-being
Time frame: Baseline, Week 8
Change in Depression Anxiety Stress Scales (DASS) scores
\- DASS scores for measures of the negative emotional states of depression, anxiety and stress
Time frame: Baseline, Week 2, Week 4, Week 8
Change in gut microbiota composition
\- Assessed by 16S rRNA gene sequencing of stool sample
Time frame: Baseline, Week 8
Change in sleep/wake time
\- Assessed with 7 consecutive days of total sleep time and wake after sleep onset measured using a wrist worn accelerometer
Time frame: Baseline, Week 8
Change in physical activity
\- Assessed with 7 consecutive days of raw acceleration, steps taken and activity counts measured using a wrist worn accelerometer
Time frame: Baseline, Week 8
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